Pfizer plans to seek Emergency Use Authorization from the Food and Drug Administration (FDA) for its COVID-19 vaccine for children ages 2-11 in September, the company’s CEO said in an earnings call on Tuesday.
"We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September,” Pfizer CEO Albert Bourla said Tuesday, also noting that the company plans to seek full FDA approval of its vaccine for ages 16 and up this month.
"While we are currently distributing our vaccine in the U.S. under an Emergency Use Authorization, we expect to submit this month a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking full approval for our Covid-19 vaccine for individuals 16 years of age and older,” Bourla said.
Full approval by the FDA could go a long way toward easing the concerns of some vaccine skeptics, as well as make it easier for the company to directly distribute and market its vaccine.
The vaccine from Pfizer-BioNTech was the first to receive EUA in the United States back in Dec. 2020, and is the most widely used of the three COVID-19 vaccines that have received such authorization. According to data from the Centers for Disease Control and Prevention (CDC), the U.S. has administered over 131 million doses of the Pfizer-BioNTech shot, with nearly 54 million Americans fully vaccinated by the two-dose jab.
Per the CDC, the U.S. has delivered over 165 million doses of the Pfizer-BioNTech shot. Bourla told investors Tuesday that Pfizer has been contracted to deliver 1.6 billion doses globally this year, and Pfizer-BioNTech expect to be able to deliver roughly 2.5 billion doses in 2021.
Pfizer also expects to produce 3 billion in 2022, welcome news for the global vaccination effort.
The additional doses worldwide could also go a long way toward booster shots, which the company is testing. Pfizer is testing boosters, and Bourla said last month in an interview with CNBC that people will "likely" require a third dose of a COVID-19 vaccination within 12 months of being fully vaccinated.
Mikael Dolsten, the company’s chief scientific officer, told investors Tuesday that they expect high-risk individuals, such as people with underlying medical conditions and the elderly, to be first in line for a booster.
Pfizer announced Tuesday that it earned $4.9 billion in the first three months of 2021, raising its profit forecast for the year thanks to strong demand for its COVID-19 vaccine. The company doubled its projections for the vaccine in 2021 from $15 billion to about $26 billion.
The earnings call comes at a precarious time for the global vaccine effort, with some advocacy groups accusing the makers of COVID-19 vaccine groups of profiteering, and lawmakers and other high-profile individuals urging that patents for the vaccines be waived or suspended to help bolster vaccine equity.